Celiac DiseasePhase 1NCT05425446
Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients
A Phase 1 study testing DONQ52 in people with Celiac Disease, run by Chugai Pharmaceutical at 21 sites in 2 countries.
Trial summary
This study is to characterize the safety and tolerability of an investigational drug called DONQ52 and consists of a single ascending dose part (Part A) and a multiple ascending dose part (Part B) in well-controlled celiac disease patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- DONQ52
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 19 Sep 2022to 17 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of medically diagnosed celiac disease based on biopsies and positive celiac serology.
- Be on a GFD for at least 12 months
- HLA-DQ2.5 genotype
- Experienced at most mild symptoms of celiac disease
Who cannot join
- Refractory celiac disease
- Positive for any of the 3 serology (-Tissue transglutaminase-2,- Deamidated gliadin peptide-IgA, and deamidated gliadin peptide-IgG)
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States18 sites
Velocity Clinical Research, Anderson
Anderson, South Carolina, 29621
Pinnacle Research Group
Anniston, Alabama, 36207
Aventiv Research, Inc.
Columbus, Ohio, 43213
Digestive Specialists Inc
Dayton, Ohio, 45414
Mountain View Clinical Research
Denver, Colorado, 80209
Long Island Gastrointestinal Research Group
Great Neck, New York, 11023
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Alliance for Multispecialty Research
Knoxville, Tennessee, 37920
Clinical Site Partners
Leesburg, Florida, 34748
Tandem Clinical Research
Marrero, Louisiana, 70072
Velocity Clinical Research - Boise
Meridian, Idaho, 83642
Lucas Research - Diabetes & Endocrinology Consultants, PC
Morehead City, North Carolina, 28557
Columbia University Medical Center
New York, New York, 10019
Care Access Research
Ogden, Utah, 84403
North Carolina Clinical Research
Raleigh, North Carolina, 27607
Mayo Clinic - Rochester
Rochester, Minnesota, 55095
Digestive Research of Central Texas
Waco, Texas, 76712
Clinical Site Partners - Orlando
Winter Park, Florida, 32789
Australia3 sites
Campbelltown Hospital
Campbelltown, New South Wales, 2560
University of Sunshine Coast Clinical Trials Centre - Morayfield
Morayfield, Queensland, 4506
Linear Clinical Research
Nedlands, Western Australia, 6009
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate The Safety, Tolerability, Pharmacokinetics, and Biomarkers of DONQ52 in Celiac Disease Patients (LILY Study)
This study is to characterize the safety and tolerability of an investigational drug called DONQ52 and consists of a single ascending dose part (Part A) and a multiple ascending dose part (Part B) in well-controlled celiac disease patients.
- Conditions
- Celiac Disease
- Being tested
- DONQ52, Placebo
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DONQ52Drug
Subcutaneous (SC) injection
PlaceboDrug
Subcutaneous (SC) injection
| Study group | Role | What they receive |
|---|---|---|
| SAD Cohort 1 | Experimental | All randomized patients will receive one dose of either DONQ52 Dose A or placebo Receives: Drug: DONQ52; Drug: Placebo |
| SAD Cohort 2 | Experimental | All randomized patients will receive one dose of either DONQ52 Dose B or placebo Receives: Drug: DONQ52; Drug: Placebo |
| SAD Cohort 3 | Experimental | All randomized patients will receive one dose of either DONQ52 Dose C or placebo Receives: Drug: DONQ52; Drug: Placebo |
| SAD Cohort 4 | Experimental | All randomized patients will receive one dose of either DONQ52 Dose D or placebo Receives: Drug: DONQ52; Drug: Placebo |
| MAD Cohort 1 | Experimental | All randomized patients will receive multiple dose of either DONQ52 Dose E or placebo Receives: Drug: DONQ52; Drug: Placebo |
| MAD Cohort 2 | Experimental | All randomized patients will receive multiple dose of either DONQ52 Dose F or placebo Receives: Drug: DONQ52; Drug: Placebo |
| MAD Cohort 3 | Experimental | All randomized patients will receive multiple dose of either DONQ52 Dose G or placebo Receives: Drug: DONQ52; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher
Incidence and severity of TEAEs and its relationship to the study drugs
Measured: Up to 246 days
Safety as assessed by Vital signs (blood pressure, body temperature, pulse rate, respiratory rate, percutaneous oxygen saturation)
Abnormality in vital signs
Measured: Up to 246 days
Safety as assessed by Electrocardiograms (ECGs; QT interval, heart rate)
Abnormality in Electrocardiograms (ECGs)
Measured: Up to 246 days
Safety as assessed by Laboratory tests (hematology, blood chemistry, coagulation and urinalysis)
Incidence of laboratory abnormalities, based on clinical laboratory tests
Measured: Up to 246 days
Secondary outcomes (6)
Pharmacokinetics; Serum DONQ52 concentration
Serum DONQ52 concentrations over time
Measured: Up to 246 days
Pharmacokinetics; Maximum serum concentration [Cmax]
Cmax of DONQ52
Measured: Up to 246 days
Pharmacokinetics; Time to maximum serum concentration [Tmax]
Tmax of DONQ52
Measured: Up to 246 days
Pharmacokinetics; Area under the serum concentration time curve [AUC]
AUC of DONQ52
Measured: Up to 246 days
Pharmacokinetics; Half life [T1/2]
T1/2 of DONQ52
Measured: Up to 246 days
Immunogenicity
Prevalence and incidence of anti-drug antibodies (ADAs) to DONQ52
Measured: Up to 246 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start19 Sep 2022
- Primary completion9 Aug 2024
- Study completion17 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sponsor Chugai Pharmaceutical Co. Ltd, Study director, clinical-trials@chugai-pharm.co.jp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425446
- Sponsor's protocol ID
- DQB101US
- Status last verified
- Jan 2025
- First submitted
- 13 Jun 2022
- Last updated
- 31 Jan 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds\_request.html).
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate The Safety, Tolerability, Pharmacokinetics, and Biomarkers of DONQ52 in Celiac Disease Patients (LILY Study)
- ClinicalTrials.gov ID
- NCT05425446
- Acronym / sponsor ID
- DQB101US
- Conditions
- Celiac Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 9 Aug 2024 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to characterize the safety and tolerability of an investigational drug called DONQ52 and consists of a single ascending dose part (Part A) and a multiple ascending dose part (Part B) in well-controlled celiac disease patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| SAD Cohort 1 | Experimental | Drug: DONQ52, Drug: PlaceboAll randomized patients will receive one dose of either DONQ52 Dose A or placebo |
| SAD Cohort 2 | Experimental | Drug: DONQ52, Drug: PlaceboAll randomized patients will receive one dose of either DONQ52 Dose B or placebo |
| SAD Cohort 3 | Experimental | Drug: DONQ52, Drug: PlaceboAll randomized patients will receive one dose of either DONQ52 Dose C or placebo |
| SAD Cohort 4 | Experimental | Drug: DONQ52, Drug: PlaceboAll randomized patients will receive one dose of either DONQ52 Dose D or placebo |
| MAD Cohort 1 | Experimental | Drug: DONQ52, Drug: PlaceboAll randomized patients will receive multiple dose of either DONQ52 Dose E or placebo |
| MAD Cohort 2 | Experimental | Drug: DONQ52, Drug: PlaceboAll randomized patients will receive multiple dose of either DONQ52 Dose F or placebo |
| MAD Cohort 3 | Experimental | Drug: DONQ52, Drug: PlaceboAll randomized patients will receive multiple dose of either DONQ52 Dose G or placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of medically diagnosed celiac disease based on biopsies and positive celiac serology.
- Be on a GFD for at least 12 months
- HLA-DQ2.5 genotype
- Experienced at most mild symptoms of celiac disease
Key exclusion criteria (2 listed)
- Refractory celiac disease
- Positive for any of the 3 serology (-Tissue transglutaminase-2,- Deamidated gliadin peptide-IgA, and deamidated gliadin peptide-IgG)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DONQ52Subcutaneous (SC) injection | Drug | MAD Cohort 1, MAD Cohort 2, MAD Cohort 3, SAD Cohort 1, SAD Cohort 2, SAD Cohort 3, SAD Cohort 4 |
| PlaceboSubcutaneous (SC) injection | Drug | MAD Cohort 1, MAD Cohort 2, MAD Cohort 3, SAD Cohort 1, SAD Cohort 2, SAD Cohort 3, SAD Cohort 4 |
Primary outcome
Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher
Time frame: Up to 246 days
Incidence and severity of TEAEs and its relationship to the study drugs
Safety as assessed by Vital signs (blood pressure, body temperature, pulse rate, respiratory rate, percutaneous oxygen saturation)
Time frame: Up to 246 days
Abnormality in vital signs
Safety as assessed by Electrocardiograms (ECGs; QT interval, heart rate)
Time frame: Up to 246 days
Abnormality in Electrocardiograms (ECGs)
Safety as assessed by Laboratory tests (hematology, blood chemistry, coagulation and urinalysis)
Time frame: Up to 246 days
Incidence of laboratory abnormalities, based on clinical laboratory tests
6 secondary outcomes
Pharmacokinetics; Serum DONQ52 concentration
Time frame: Up to 246 days
Pharmacokinetics; Maximum serum concentration [Cmax]
Time frame: Up to 246 days
Pharmacokinetics; Time to maximum serum concentration [Tmax]
Time frame: Up to 246 days
Pharmacokinetics; Area under the serum concentration time curve [AUC]
Time frame: Up to 246 days
Pharmacokinetics; Half life [T1/2]
Time frame: Up to 246 days
Immunogenicity
Time frame: Up to 246 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).
Related trials for Celiac Disease
Active, not recruitingEarly Phase 1
VTP-1000 in Adults With Celiac Disease
Celiac Disease
RecruitingObservational study
Impact of Mediterranean Diet and Processed Food Consumption on Gastrointestinal Symptoms in Coeliac Patients on a Gluten-Free Diet
Celiac Disease, Gluten-free Diet
Recruiting
GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)
Celiac Disease in Children, Nutrition Disorder, Child
RecruitingObservational study
Celiac Disease Genomic Environmental Microbiome and Metabolomic Study
Celiac Disease
RecruitingObservational study
Pathogenic Study of Adult Immune Enteropathies
Celiac Disease, Autoimmune Enteropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sponsor Chugai Pharmaceutical Co. Ltd study director
clinical-trials@chugai-pharm.co.jp
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DONQ52 in people with Celiac Disease, run by Chugai Pharmaceutical at 21 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher (time frame: Up to 246 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.